Medical stapler



April 6, 1965 Filed Sept. 19, 1962 R. F. MALLINA MEDICAL STAPLER 3 Sheets-Sheet 1 INVENTOR:

HIS A TTORNEX April 6, 1965 R. F. MALLINA 3,176,896

MEDICAL STAPLER Filed Sept. 19. 1962 a Sheets-Sheet 2 A 35a I j, 43,52

INVENTOR: R DOLPH F MALUNA,

Hi5 ,9 TTDR/VEX April 6, 1965 R. F. MALLINA 76, 6

MEDICAL STAPLER Filed Sept. 19, 1962 3 Sheets-Sheet 3 INVENTOR:

J RUDOLPH F. MALuNA,

HIS flTTO/ZNEX United States Patent 3,176,896 MEBECAL STAPLER Rudolph F. Mallina, Hastings on Hudson, N.Y., assignor to Foundation for Medical Technology, a corporation of New York Filed Sept. 19, 1962, Ser. No. 224,816 14 Claims. (Cl. 227-49) The invention relates to surgical instruments, and relates more particularly to medical stapling instruments or staplers for the anastornosis of circulatory vessels, such as the joining of blood vessels and similar linear structures such as lymphatics, nerve fascicles, tendons, and the like.

The most conventional way of reconnecting a severed blood vessel is by manual suturing, in which the surgeon uses a curved needle with a silk thread attached and held in specially designed forceps to sew the ends of a vessel together for re-establishing therein the flow of blood. In large vessels, this type of anastomosis, however time consuming and demanding of surgical skill, produces a reasonably satisfactory connection between the two vessel ends. For small vessels, however, this type of connection becomes dithcult; for very small blood vessels,

which may have a diameter of 2 mm. or smaller, suturing of the ends by hand is a difiicult and often impossible task.

It is accordingly among the principal objects of the invention to provide a stapler with the aid of which the ends of circulatory vessels may be re-connectcd safely and reliably, equally well for large, for small, and even for very small vessels.

It is another object of the invention to provide such a stapler that is reliable in use and easy to sterilize, and to maintain sterile.

Reference is had to the application Ser. No. 154,187, filed November 22, 1961, by Rudolph F. Mallina, the instant applicant, jointly with Theodore R. Miller, assigned to Foundation for Medical Technology, now Patout No. 3,144,654, dated August 18, 1964.

It is among the principal objects of the instant improvement to provide a bushing for medical staplers that has a built-in vessel clamp to restrain vessel slippage before and during the stapling.

It is a further object of the instant improvement to provide a simplified cufiing clamp.

It is still anot er object of the instant improvement to provide improved locking and ejection means for the bushing parts with relation to the stapler.

Other objects of the invention will in part be obvious and will in part appear hereinafter.

The invention accordingly comprises the features of construction, combination of elements and arrangement of parts which will be exemplified in a construction hereinafter set forth and the scope of the application of which will be indicated in the claims.

In the accompanying drawings,

FIG. 1 is a plan view of an assembled stapler in accordance with the invention;

FIG. 2 is a front elevational view thereof;

FIG. 3 is a fragmentary large scale front elevational view of a detail indicated only imperfectly in FIG. 2;

FIG. 4 is a fragmentary large scale sectional view taken on the line 4 of FIG. 3;

FIG. 5 is a fragmentary large scale elevational view partly in section, showing two vessel ends about to be stapled;

FIG. 6 is a fragmentary large scale elevational view partly in section, showing two stapled vessel ends;

FIG. 7 is an extended view, in perspective, of one staple bushing part with staples and a staple driver, and one anvil bushing part;

FIG. 8 is a large scale fragmentary front elevational view, partly in' section, showing the locking and ejecting mechanism for the bushing part; and

FIG. 9 is a large scale schematic view of a detail relating to the culling clamp, its dimension and position relative to=the bushing.

In carrying the invention into elfect in the embodiment which has been selected for illustration in the accompanying drawings and for description in this specification, and referring now particularly to FIGS. 1 and 2, there is provided a medical stapler generally indicated at 21.

The staplei General description The stapler 21 comprises forcep means and includes two sections, namely a stapler section 22 and an anvil section 23. Each of the sections 22 and 23 is formed of a pair of forceps, as best shown in FIG. 2, and each pair of forceps comprises two releasably interengaging handles 24 that are pivoted at 24a, and jaws 34.

Means 26 are provided, such as a hinge pin 26a and an apertured boss 26b for releasably interengaging the two sections 22 and 23; and registry means 27 are provided for locating and properly positioning the front parts of the sections 22 and 23 relative to each other, and may include a register pin 27a on one section and an aperture 271; on the other. The hinge pin 26a and the register pin 27a are at right angles to each other.

The foregoing and some other parts mentioned subsequently herein are either identical with, or similar to, corresponding parts in the aforesaid earlier application 8er. No. 154,187, and wherever the discussion of these parts in the said earlier application is more detailed than herein, such fuller discussion is incorporated herein by reference.

Adjustable means 28 are provided, such as a nut 29 and screw on one section and an abutment plate 31 on the other, for adjusting the force with which the two front ends of the sections 22 and 2 3 are pressed together, in order to regulate the pressure with which the parts of the vessel to be stapled (see FIGS. 5, 6) are held in contact.

Bushings, each of two bushing parts Each section carries a bushing, namely the stapler section 22 carries a stapler bushing 32, and the anvil section 23 an anvil bushing 33.

Taking the stapler bushing 32 as an illustration, each bushing is composed of two parts, an upper part 32a and a lower part 32b. Similarly, the anvil bushing 33 is composed of an upper part 33a, and of a lower part (not shown).

Each bushing is held in the jaws 34 of the respective section, and after the stapling, the surgeon will unlock and push apart the handles 2 to open the jaws 34 to re lease the bushings. Means are provided, such as a locking and ejection device connected to each jaw for locking and ejecting, respectively, the respective bushing part. Thus, the upper jaw 34:: for the upper bushing part 32a comprises a locking and ejection device 36a, and the lower jaw 34b a locking and ejection device 36b (see FIG. 2).

As best shown in FIG. 8, on the upper jaw 34a there is slidably mounted a lug 37a that is held slidably by means of a retainer 370 of well-known conventional construction, and has an aperture 37b through which there protrudes a lever 46, and by this lever the lug 37a is movable in opposite directions R, F between a rearward and a forward position (the forward position being shown in solid lines in FIGS. 3 and 8). These positions, as explained below, correspond to the forwardmost position III and rearwardmost position I, respectively, of the lever 46 for the lug 37a. Y

The lower jaw 34b.(FIG. 4) has a similar lug 37b.

Each lug 37a, 371) (FIG. 4) comprises a U-shaped portion 37:: that engages in slideable relationship the outer surfaces of the respective jaw, and a resilient extended section 37d. The extended section 37d of the upper jaw 34a overlies and slides on the top surface of the upper jaw 34a, and the extended section 37d of the lower jaw 34b adjoins and slides on the bottom surface of the lower jaw 34b. Each extended section 37d is slightly curved upwardly to engage resiliently the projecting'arm 37 of the retainer 37c, which arm extends across the outer surface of the resilient extended section 37d and holds the latter in place. I

The bushing part 32a has a first cam follower or locking tooth 38 which includes an inclined surface. The lug 37a has a first cam 39 which, when it is moved forwardly in the direction F, engages the first cam follower 38 thereby locking the bushing part 32a in position in the jaw 34a.

Registry means, such as a protuberance or nipple 41, are formed on each bushing part, and each jaw has a corresponding aperture 42a and 42b, respectively, for properly positioning the bushing part relativeto the jaw when it is locked by the interengagement of first cam and cam follower 39 and 38.

Similar to the upper and lower parts 32a, 32b, respectively, of the bushing 32, the parts 41a, 42a refer to the upper nipple and upper aperture, and the parts 41b and 42b to the lower nipple and to the lower aperture, respectively.

, A second cam 43 is formed on the lug 37a, and cooperates during rearward movement in the direction R with a second cam follower such as a surface 44 of the bushing part to eject the bushing part downwardly.

The lug is movable by means of the lever 46, between a rearwardmost position I and a forwardmost position III; detent means 47 may be provided to retain the lug 37 in either extreme position I or III. Aneutral position II may be provided which serves to permit the loading of the staple bushing port, in which positionthe cams and locking teeth are out of engagement with their respective cam followers on the bushing parts.

Each of the bushings, namely each stapler bushing 32 as well as each anvil bushing 33, defines on its interior a passage 48 for one end of a circulatory vessel A, the severed ends of which are to be stapled.

Internal vessel clamps Each bushing 32, 33 forms in the passage 48 vessel clamp means 49, such as an upper clamp tooth 51 and a lower clamp tooth 52. These clamp teeth 51 and 52 have a serrated surface, defining therebetween an undulat bushing part 32a generally is exactly like the lower part 32b, the exception is that the clamp tooth 51 of the upper part is complementary, rather than symmetrical, relative to the clamp tooth 52 of the lower bushing part 321;.

The same may be said about the parts of the anvil bushing 33; namely, the upper and lower parts are alike except for their respective clamp teeth 51' and 52.

The staple bushing Each staple bushing part 32a, 32b has on its interior one or more receptacles 54, each having staples 56. The receptacle intersects the front face 57 in an arcuate aperture or apertures 58 which form the staple exit port or ports. .Astaple' driver 59 is provided which has two or 4,. more fingers 60 reaching into each receptacle 54 to expel the staples 56 out of the respective ports 58.

The driver 59, for'instance of the upper bushing part 32a, (see FIG. 7) is retained between the curved inner surface 59a of the bushing part 32aand the flanges 59b and 590 thereof, while the fingers 60 will protrude with their forward portions into the receptacles 54 (see FIG. 4).

As best shown in FIGS; 1 and 4, the stapler 21 includes a staple lever 61 for propelling the staple driver 59.

The anvil bushing In contrast thereto, the parts of the anvil bushing 33 are provlded at the front face 62 with a hard surface.

Materials The material of the bushing parts 32a and 32b is a non-metallic molded material, for instance an acetal resin that has a high meltingpoint and is a crystalline, thermoplastic polymer known under the trademark Delrin, or other heat or chemically stable material. The hard surface of the front face 62, however, may be metal, for instance applied to the surface 62 bymetal spraying or other suitable metal applying processes. The metal may be stainless steel, and may'also consist of a thin plate made adhering to the surface 62. The metal may be stainless steel or the like, if desired; the entire anvil bushing 33, however, may instead be made of metal such as stainless steel or other hard material, for instance glass.

The driver 59 may be made of stainless steel or a cobalt chromium known under the trademark Vitalium. Likewise, the parts of the forceps .as well as the staple lever 61, and the cuffing clamp to be discussed later, may be made of stainless steel or of similar biologically inert materials such as Vitalium.

The cufiing clamp Two cuffing clamps 63 are provided for each bushing 32, 33, thereby making a total of four clamps 63. Each cufling clamp 63 is assigned to a bushing part such as 32a, 32b, 33a, 33b, and is pivoted at 64 to turn about the axis of the pivot 64 as a fulcrum. As best shown in FIGS. 2, 3, and 9, each cuffing clamp 63 comprises a lever 66 and a front portion that has an outer prong 67 and an inner prong 68. Each prong thus is resilient, and

its forward ends'terminate in inner edges 69 and 71, separated by a certain distance a. Each cufling clamp 63 is so dimensioned, and the fulcrum pivot 64 is so spaced from the center C of the bushings 32, 33 respectively, that the edges 69 and 71 are sufiiciently far apart for a variety of sizes of bushings.

Example In a specific example, X was .798 in., and Y .188 in.; the center angle Q between the center C and the edges 69 and 71' along the outer periphery of the particular bushing was about 58.

It is the purpose of theinstant particular cufling clamp V to make 'a two-point contact on the outside diameter of various sizes of bushing. The range may be in the ratio of about 1 to 2.5. Within this range, the angle Q ranges from about to 60. The points 69 and 71 will always be close to the surface of the bushing along the outer diameter D thereof, thereby clamping the cuffed vessel with substantially equal force. By way of exempli fication, specifically, the following bushings may be used:

The largest of the outside diameters D of the bushing 32, 33 is about 2.5 times the size of the smallest bushing outside diameter D.

As best shown in FIGS. 4 and 7, each bushing part carries a rim of teeth 72 over which the end of the vessel A is cufied (FIG. 4), and then the ending clamp 63 is applied.

FIG. 5 shows the stapling principle, and FIG. 6 the completed stapled vessel.

The operation is as follows:

Each bushing part is positioned in its respective open jaw 34 of the forceps, and is locked in position by rocking the lever 46 in the direction F to the forwardmost position HI. -Thereafter one of the severed ends of the vessel A is introduced between the two parts 32a, 32b of one bushing 32, and the other end between the two parts 33a, 33b of the other bushing 33.

Then the operator will close the jaws 34 by bringing together and interlocking the handles 24. By this closing, each of the two bushing parts will complete the respective bushing, and the vessel clamp means 49 thereof will clamp a portion of the vessel, as shown in FIGS. 3 and 4.

Thereafter, the vessel end will be turned over the rim of teeth 72 and the cuff will come to lie on the outer surface 73 of the bushing. This outer surface 73 has the diameter D shown in FIG. 9. Subsequently, the cufiing clamp 63 is applied.

Thereafter, the two sections 22 and 23 are coupled to gether by means of means 26, and registered with the registering means 27, and the force between the two cuffed vessel ends adjusted by means of the adjustable means 28.

The surgeon will now apply the staple lever 61, so that the staples 56 will be driven through the adjoining cutfed vessel ends (FIG. 6).

Thereafter the operator will open the cufing clamps 63, move the four ejecting levers 46 rearward (from the position III to the position I) and then will spread apart the handles 24. The opening of the jaws 34 and the spring force of the cam 43 will then release the bushings.

The bushings are disposable and need not be re-used.

I wish it to be understood that I do not desire to be limited to the exact details of construction shown and described, for obvious modifications will occur to a person skilled in the art.

Having thus described the invention, what I claim as new and desire to be secured by Letters Patent, is as follows:

1. In a suturing stapler having forceps means, in combination, two bushings each comprising two opposite parts positionable on the forceps means and defining on its interior a central passage for one end of a severed circulatory vessel, means operable for clamping at least a portion of said vessel end to restrain accidental removal thereof from said passage of each bushing, and means operable for holding releasably each severed end of the vessel culfed over a bushing comprising a toothed rim formed on the exterior of each bushing adapted to receive the cuffed vessel end so that the cuff will be positioned adjacent the outer surface of the bushing, and two cutting clamps for each bushing operable to engage the cuff on opposite sides of the outer bushing surface, each cuifing clamp having two cuff engaging edges spaced apart from each other for a certain distance in one plane and being pivoted on the forceps means about a fulcrum so positioned relative to the axis of the bushing, and said certain distance being so dimensioned, that both edges of each cufiing clamp will engage two points of a semicircular portion of the cuff on the bushing within a range of bushings having diameters of said outer surface from unity to about 2.5 times unity.

2. In a suturing stapler having forceps means, in combination, two bushings each comprising two opposite parts positionable in the forceps means and defining on its interior a central passage for one end of a severed circulatory vessel, means operable for clamping at least a portion of said vessel end to restrain accidental removal thereof from said passage of each bushing, and means operable for holding releasably each severed end of the vessel cuffed over a bushing comprising a toothed rim formed on the exterior of each bushing adapted to receive the cuffed vessel end so that the cuff will be positioned adjacent the outer surface of the bushing, and two cufiing clamps for each bushing operable to engage the cuff on opposite sides of the outer bushing surface, each cutting clamp having two cuif engaging edges spaced apart from each other for a distance in one plane and being pivoted on the forceps means about a fulcrum so positioned relative to the axis of the bushing, that both edges of each cufiing clamp will engage two points of a semicircular portion of the cuff on the bushing within a range of bushings having diameters of said outer surface of from 2.25 millimeters to 4.45 millimeters, and said edges forming with the bushing center an angle ranging, respectively, from to 60.

3. In a suturing stapler, in combination, two bushings each comprising two oppositely positionable parts and defining on its interior a central passage for a circulatory vessel, and means operable for releasably connecting and respectively ejecting each bushing part to a stapler portion, and a locking and ejecting device movable in opposite directions on said stapler portion between opposite positions, first and second cam and cam follower means formed on said device and bushing part, the first cam and cam follower during movement of said device in one direction interengaging to lock the bushing part in position on the stapler and, respectively, releasing it during movement of said device in the opposite direction, the second cam and cam follower interengaging during movement of said device in the said opposite direction thereby ejecting the bushing part and, respectively, clearing the path of the bushing part during movement of said device in the said one direction during positioning of the bushing part, and registering means formed on said bushing part operable for guiding the bushing part to and from its pro-determined position on the stapler during locking and, respectively, ejection by the locking device.

4. A bushing part, for use together with a second bushing part to complete a bushing releasably positionable in a suturing stapler, comprising a non-metallic molded one-piece body including a neck portion to complete with a corresponding portion of the second bushing part a projecting tube defining a central passage for a circulatory vessel, said bushing part having near its front end ports adapted for staple exiting, and said bushing part including vessel clamping means projecting toward the passage axis rearwardly of said staple exit ports into said passage and adapted to co-operate with corresponding projecting clamping means of the second bushing part for engaging and clamping therebetween at least a portion of said vessel in the passage.

5. A bushing part, as claimed in claim 4, said clamping means comprising a serrated tooth structure.

6. A bushing part, as claimed in claim 4, said body having a staple receiving chamber, and a staple pusher extending into said chamber and being operable to expel the staple from the chamber.

7. A bushing part, as claimed in claim 4, said body having a series of separate staple receptacles, and a staple ing part to complete'a bushing releasably positionable in a' suturing stapler, comprising anon-metallic molded onepiece body including a neck portion to complete with a corresponding portion of the second bushing part a projecting tube defining a central passage for a circulatory vessel, said bushing part including vessel clamping means projecting into said passage and adapted to co-operate with corresponding projecting clamping means of the sec- ,ond bushing part for engaging and clamping therebetween at least a portion of said vessel in the passage, and a hard layer disposed on the front surface of saidbushing part and having depression cam surfaces for staple end guiding.

9..A staple bushing, for use in connection with a stapler and formed of two oppositely held parts releasably positioned in the stapler, each bushing part comprising a nonmetallic molded one-piece bushing, said bushing having near its front end ports adapted for staple exiting, and

defining on its interior a central passage for a circulatory vessel, andclamping means formed on said bushing parts projecting into said passage towards the passage axis rearwardly of said staple exit ports co-operat-ing when said bushing is completed in the stapler to clamp therebetween at least a portion of said vessel in the passage.

10 A staple bushing, as claimed in claim 9, together with, registering means formed on each bushing part and adapted to position said bushing on said stapler.

. 11. A bushing, for use in connection with a stapler and formed of two oppositely held parts releasably positioned in the stapler, each bushing part comprising a non-metallic molded one-piece bushing, said bushing having near its front end ports adapted for staple exiting, and defining on its interior a central passage for a circulatory vessel, each bushing part having a projection protruding into said passage towards the passage axis rearwardiy of said staple exit ports, the projections of both parts of thebushing co-opera-ting, when the bushing is completed in the stapler, to clamp therebetween at least a portion of said vessel in the :passage.

l2. A bushing, for use in connection with a stapler and formed of two oppositely held parts releasably positioned in the stapler, each bushing part comprisinga non-metallic molded one-piece bushing, said bushing having a front end and defining on its interior a central passage for a.

circulatory vessel extending rearwardly of said front end, and clamping means comprising a structure formed on each bushing part having a serrated end surface, said end surfaces of said parts when the parts are assembled to complete the'bushing in the stapler defining therebetween an undulating path in said passage rearwardly of said front end, said surfaces clamping at least a portion of said vessel saidrpath thereby restraining removal of the vessel from said passage. 1

13. A staple bushing, as claimed in claim 12, the undulating path including at least one and one-half wavelike sections, each section'bending the vessel portion, whereby the clamped vessel portion is bent at least three times.

14. A staple bushing, as claimed'in'claim 12, and a toothed rim formed on the exterior of said bushing arranged to engage frictionally the end portion of the circulatory vessel extending through said passage and being cufied over the rim; 7

i References Cited by the Examiner UNITED STATES PATENTS 2,618,268 11/52 English 128-346 X r 2,940,451 6/60 Vogelfanger et al 1349 X 2,965,900 12/ Inokouchi 1-349 X 3,101,715 8/63 Glassman 128-322 GRANVILLE Y. CUSTER, JR., Primary Examiner. 

1. IN A SUTURING STAPLER HAVING FORCEPS MEANS, IN COMBINATION, TWO BUSHINGS EACH COMPRISING TWO OPPOSITE PARTS POSITIONABLE ON THE FORCEPS MEANS AND DEFINING ON ITS INTERIOR A CENTRAL PASSAGE FOR ONE END OF A SEVERED CIRCULATORY VESSEL, MEANS OPERABLE FOR CLAMPING AT LEAST A PORTION OF SAID VESSEL END TO RESTRAIN ACCIDENTAL REMOVAL THEREOF FROM SAID PASSAGE OF EACH BUSHING, AND MEANS OPERABLE FOR HOLDING RELEASABLY EACH SEVERED END OF THE VESSEL CUFFED OVER A BUSHING COMPRISING A TOOTHED RIM FORMED ON THE EXTERIOR OF EACH BUSHING ADAPTED TO RECEIVE THE CUFFED VESSEL END SO THAT THE CUFF WILL BE POSITIONED ADJACENT THE OUTER SURFACE OF THE BUSHING, AND TWO CUFFING CLAMPS FOR EACH BUSHING OPERABLE TO ENGAGE THE CUFF ON OPPOSITE SIDES OF THE OUTER BUSHING SURFACE, EACH CUFFING CLAMP HAVING TWO CUFF ENGAGING EDGES SPACED APART FROM EACH OTHER FOR A CERTAIN DISTANCE IN ONE PLANE AND BEING PIVOTED ON THE FORCEPS MEANS ABOUT A FULCRUM SO POSI- 